CT ScansNCT06965790
Study on Sex-specific, Individualized Dose Calculation of Contrast Agent in CT Examinations
A study testing contrast media (Imeron 350, active ingredient Iomeprol) volume according to sex-specific blood volume in people with CT Scans and Contrast Media, run by University Hospital Augsburg at 1 site in Germany.
Trial summary
A large proportion of radiological CT examinations require the intravenous administration of iodine-containing X-ray contrast medium. According to current guidelines, the amount required for CT examinations in the (portal) venous phase is calculated on the basis of body weight (e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CT Scans, Contrast Media, Gender
- What is being tested?
- contrast media (Imeron 350, active ingredient Iomeprol) volume according to sex-specific blood volume
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of a justifying indication for a CT scan of the thorax and abdomen with application of intravenous contrast medium and a start delay corresponding to the portal venous contrast medium phase
- Ability to give informed consent, as well as written and verbal consent to participate in the study available
Who cannot join
- Cardiorespiratory instability (as assessed by the attending physician)
- Age <18 years
- Existing or suspected pregnancy
- Known post hepatectomy and/or splenectomy
- Lack of current height (in the same inpatient/outpatient hospital stay) or lack of possibility of height measurement
- Lack of current daily body weight or inability to measure body weight
Show all 9Show fewer
- Height under 140 cm or over 220 cm
- Body weight under 50 kg or over 120 kg
- Contraindication to iodine-containing contrast medium (Allergy to contrast media containing iodine, Severe renal insufficiency (eGFR < 30 ml/min), Hyperthyroidism)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hosptial Augsburg
Augsburg, Bavaria, 86157
Josua Decker, PD MD, 00498214002441, radiologie-studien@uk-augsburg.de
About this study
Official title: Randomized Controlled Study on Sex-specific, Individualized Dose Calculation of Intravenously Administered Contrast Agent in CT Examinations in Portal Venous Phase to Achieve Equivalent Contrast in Men and Women
A large proportion of radiological CT examinations require the intravenous administration of iodine-containing X-ray contrast medium. According to current guidelines, the amount required for CT examinations in the (portal) venous phase is calculated on the basis of body weight (e.g. 0.2-0.4 g iodine/kg body weight), but a standardized application dose of the contrast agent is often also used.
In earlier studies, the investigators found that the iodine contrast in vessels and organs achieved with a standardized amount of contrast agent differs significantly between women and men. On average, women showed around 10% higher iodine contrast than men of the same height and weight. The investigators attribute these differences to physiological, sex-specific differences in blood volume. For example, the blood volume of a woman 175 cm tall and weighing 75 kg is approx. 400 ml less than that of a man of the same height and weight (approx. 4.6 vs. 5.0 l, calculated according to Nadler). Taking blood volume into account, sex was no longer a significant influencing factor in a retrospective cohort (n=274).
Read more
The investigators would now like to investigate these results in a prospective study. For this purpose, two groups of patients with a clinical indication for a contrast-enhanced CT scan in the venous phase will be compared:
- control group with regular weight-adjusted (n = 200)
- study group with dosing according to blood volume (n = 200).
The hypothesis is that the application scheme adapted to the blood volume leads to a more homogeneous contrasting of women and men. In order to quantify this effect, the iodine contrast values of both groups will be quantitatively analyzed, taking into account other influencing variables (height, weight).
The investigators hope that this approach will reduce or even eliminate the observed sex-specific differences. This would lead to a sex-equal contrast based on an individualized amount of contrast medium.
- Conditions
- CT Scans, Contrast Media, Gender, Womens Health
- Being tested
- contrast media (Imeron 350, active ingredient Iomeprol) volume according to sex-specific blood volume
- Keywords
- CT, CT Scans, Contrast Media, contrast, gender
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast media (Imeron 350, active ingredient Iomeprol) volume according to sex-specific blood volumeDrug
Calculation of the standardized contrast agent (Imeron 350, active ingredient Iomeprol) quantity (0.35 g iodine/kg) and calculation of the specific blood volume using the established Nadler formula for male and female. Adjustment of the contrast agent according to the ratio of the blood volumes. The amount of saved contrast agent is replaced 1:1 by NaCl.
| Study group | Role | What they receive |
|---|---|---|
| weight adjusted contrast media volume | No intervention | control group with regular weight adjusted dosing |
| blood volume adjusted contrast media volume | Active comparator | study group with dosing according to sex-specific blood volume Receives: Drug: contrast media (Imeron 350, active ingredient Iomeprol) volume according to sex-specific blood volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sex-specific contrast difference in the vessels and organs
Achieved iodine contrast (Hounsfield units) in vessels and organs
Measured: 1 year
Contrasting the organs after adjusting the application dose of the contrast agent to the specific blood volume
Achieved iodine contrast (Hounsfield units) in vessels and organs
Measured: 1 year
Secondary outcomes (3)
Evaluation of whether the adapted blood volume formula according to Nadler can be used to achieve the minimum amount of contrast medium required to ensure sufficient contrast
Quantitative measurements of the attenuation of the liver, the portal vein, the aorta, the spleen and the kidneys by placing circular ROIs on CT-series. Mean and standard deviation of CT-values are obtained from contrast enhanced series, iodine maps and virtual non-contrast series. The measurements are performed by blinded physicians using anonymized data on a dedicated workstation.
Measured: 1 year
Evaluation of the contrast values achieved that still allow sufficient assessment of the vessels and organs.
Quantitative measurements of the attenuation of the liver, the portal vein, the aorta, the spleen and the kidneys by placing circular ROIs on CT-series. Mean and standard deviation of CT-values are obtained from contrast enhanced series, iodine maps and virtual non-contrast series. The measurements are performed by blinded physicians using anonymized data on a dedicated workstation.
Measured: 1 year
Comparison of the diagnostic accuracy of DECT/MECT-based imaging of vascular and organ structures.
Quantitative measurements of the attenuation of the liver, the portal vein, the aorta, the spleen and the kidneys by placing circular ROIs on CT-series. Mean and standard deviation of CT-values are obtained from contrast enhanced series, iodine maps and virtual non-contrast series. The measurements are performed by blinded physicians using anonymized data on a dedicated workstation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Apr 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CT ScansStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965790
- Sponsor's protocol ID
- 24040
- Status last verified
- Dec 2025
- First submitted
- 25 Mar 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study on Sex-specific, Individualized Dose Calculation of Intravenously Administered Contrast Agent in CT Examinations in Portal Venous Phase to Achieve Equivalent Contrast in Men and Women
- ClinicalTrials.gov ID
- NCT06965790
- Acronym / sponsor ID
- 24040
- Conditions
- CT Scans, Contrast Media, Gender, Womens Health
- Keywords
- CT, CT Scans, Contrast Media, contrast, gender
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A large proportion of radiological CT examinations require the intravenous administration of iodine-containing X-ray contrast medium. According to current guidelines, the amount required for CT examinations in the (portal) venous phase is calculated on the basis of body weight (e.g. 0.2-0.4 g iodine/kg body weight), but a standardized application dose of the contrast agent is often also used.
In earlier studies, the investigators found that the iodine contrast in vessels and organs achieved with a standardized amount of contrast agent differs significantly between women and men. On average, women showed around 10% higher iodine contrast than men of the same height and weight. The investigators attribute these differences to physiological, sex-specific differences in blood volume. For example, the blood volume of a woman 175 cm tall and weighing 75 kg is approx. 400 ml less than that of a man of the same height and weight (approx. 4.6 vs. 5.0 l, calculated according to Nadler). Taking blood volume into account, sex was no longer a significant influencing factor in a retrospective cohort (n=274).
The investigators would now like to investigate these results in a prospective study. For this purpose, two groups of patients with a clinical indication for a contrast-enhanced CT scan in the venous phase will be compared:
- control group with regular weight-adjusted (n = 200)
- study group with dosing according to blood volume (n = 200).
The hypothesis is that the application scheme adapted to the blood volume leads to a more homogeneous contrasting of women and men. In order to quantify this effect, the iodine contrast values of both groups will be quantitatively analyzed, taking into account other influencing variables (height, weight).
The investigators hope that this approach will reduce or even eliminate the observed sex-specific differences. This would lead to a sex-equal contrast based on an individualized amount of contrast medium.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weight adjusted contrast media volume | No intervention | –control group with regular weight adjusted dosing |
| blood volume adjusted contrast media volume | Active comparator | Drug: contrast media (Imeron 350, active ingredient Iomeprol) volume according to sex-specific blood volumestudy group with dosing according to sex-specific blood volume |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of a justifying indication for a CT scan of the thorax and abdomen with application of intravenous contrast medium and a start delay corresponding to the portal venous contrast medium phase
- Ability to give informed consent, as well as written and verbal consent to participate in the study available
Key exclusion criteria (9 listed)
- Cardiorespiratory instability (as assessed by the attending physician)
- Age <18 years
- Existing or suspected pregnancy
- Known post hepatectomy and/or splenectomy
- Lack of current height (in the same inpatient/outpatient hospital stay) or lack of possibility of height measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contrast media (Imeron 350, active ingredient Iomeprol) volume according to sex-specific blood volumeCalculation of the standardized contrast agent (Imeron 350, active ingredient Iomeprol) quantity (0.35 g iodine/kg) and calculation of the specific blood volume using the established Nadler formula for male and female. Adjustment of the contrast agent according to the ratio of the blood volumes. The amount of saved contrast agent is replaced 1:1 by NaCl. | Drug | blood volume adjusted contrast media volume |
Primary outcome
Sex-specific contrast difference in the vessels and organs
Time frame: 1 year
Achieved iodine contrast (Hounsfield units) in vessels and organs
Contrasting the organs after adjusting the application dose of the contrast agent to the specific blood volume
Time frame: 1 year
Achieved iodine contrast (Hounsfield units) in vessels and organs
3 secondary outcomes
Evaluation of whether the adapted blood volume formula according to Nadler can be used to achieve the minimum amount of contrast medium required to ensure sufficient contrast
Time frame: 1 year
Evaluation of the contrast values achieved that still allow sufficient assessment of the vessels and organs.
Time frame: 1 year
Comparison of the diagnostic accuracy of DECT/MECT-based imaging of vascular and organ structures.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contrast media (Imeron 350, active ingredient Iomeprol) volume according to sex-specific blood volume in people with CT Scans and Contrast Media, run by University Hospital Augsburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Wollny, Dr. (0049 (0) 821 400 ext. 2975, radiologie-studien@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sex-specific contrast difference in the vessels and organs (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.